Silmet Ltd.
⚠️ Moderate Risk
FEI: 4108 • Or Yehuda, Tel-Aviv • ISRAEL
FEI Number
4108
Location
Or Yehuda, Tel-Aviv
Country
ISRAELAddress
12, Ha-Sadna, , Or Yehuda, Tel-Aviv, Israel
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2022 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Southeast Imports (DSEI) | |
| 3/20/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/20/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/20/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/20/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/20/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/20/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/20/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/17/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/26/2004 | 53JA99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/26/2004 | 63TDY99DENTAL RESTORATION AGENT N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/26/2004 | 63TDY99DENTAL RESTORATION AGENT N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/26/2004 | 63TDY99DENTAL RESTORATION AGENT N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/26/2004 | 63TDY99DENTAL RESTORATION AGENT N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Silmet Ltd.'s FDA import refusal history?
Silmet Ltd. (FEI: 4108) has 14 FDA import refusal record(s) in our database, spanning from 1/26/2004 to 10/17/2022.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Silmet Ltd.'s FEI number is 4108.
What types of violations has Silmet Ltd. received?
Silmet Ltd. has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Silmet Ltd. come from?
All FDA import refusal data for Silmet Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.